ACTION ALERT: Protect Patient Use of Compounded Medications
Tuesday, April 30, 2019
Organizations in the field of integrative and natural medicine have launched a coordinated campaign to protect patient access to compounded medications. Despite a long history of safe use and patient need, the FDA has blocked patient access to ingredients used in compounded medications and is in the process of reviewing and potentially blocking access to more than 300 compounded ingredients needed by hundreds of thousands of patients. The groups are now in phase 2 of their fight against the FDA over-reach, constructing a Citizen's Petition.
Why is the FDA trying to remove them?
The 2013 Drug Quality & Security Act (DQSA) was passed in response to a meningitis outbreak from contaminated sterile drugs compounded that tragically resulted in dozens of deaths. The law gives the FDA new authority to regulate some compounding facilities to address these safety concerns.
In passing the DQSA, Congress made clear statements noting the importance of ensuring that the new compounding regulations should not interfere with the practice of medicine.
Unfortunately, the FDA’s CURRENT default position is that if there is an FDA-approved Pharmaceutical Drug for a specific condition, then a compounded substance is unnecessary - despite the needs of thousands of patients who may not be able to use the FDA pharmaceutical safely.
*The actions of the FDA are the exact opposite of what Congress intended.*
How are patients directly impacted by the new FDA regulations?
Removing Drugs From Ability to Compound
The FDA requested that substances that are currently compounded be nominated for a review process to determine indications for use, history of use, safety, etc. Over 300 ingredients were nominated. The FDA divided these into three categories:
-Category I - 55 substances that the FDA agreed to review in the Pharmacy Compounding Advisory Committee
-Category II - 4 substances that were deemed too dangerous to compound and immediately banned.
-Category III - Over 260 substances that the FDA determined there was not enough evidence to support and will not even review. This list will be banned from compounding use without any review, and includes many herbs and natural substances.
Learn more about the issue and how you can help HERE.